NCT01024140已完成不适用
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Northern California Institute of Research and Education0 个研究点目标入组 16 人开始时间: 2003年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- The Clinician Administered PTSD Scale
研究概览
简要总结
The primary aim of this pilot study is to test the efficacy of the selective serotonin re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD) in an open clinical trial.
A secondary aim is to determine whether treatment with escitalopram increases plasma allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels are correlated with treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event that occurred at least 6 months prior to evaluation.
排除标准
- •Lifetime history of bipolar or any psychiatric disorder with psychotic features.
- •Prominent suicidal or homicidal ideation.
- •History of alcohol abuse/dependence within the past 3 months.
- •History of drug abuse/dependence within the past 6 months.
- •Subjects who plan to start a new form of psychotherapy during the protocol.
- •History of sleep apnea, neurological disorder and/or current systemic illness affecting central nervous system function.
- •History of myocardial infarction in the past year.
- •Subjects on antipsychotic medications, systemic steroid medication, antidepressants, mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
- •Use of Citalopram or Escitalopram within the past 6 months.
研究组 & 干预措施
Escitalopram
Experimental
Flexible dose (5-20mg/day) of escitalopram monotherapy.
干预措施: Escitalopram (Drug)
结局指标
主要结局
The Clinician Administered PTSD Scale
时间窗: Administered at baseline (prior to treatment) and week 12
次要结局
- Social Adjustment Scale(Initial, Mid-Trial and Final Assessments)
- Quality of Life Inventory(Initial, Mid-Trial and Final Assessments)
- PTSD Checklist(Each Visit: Week 0, 2, 4, 6, 8, & 12)
- Beck Depression Inventory(Each Visit: Week 0, 2, 4, 6, 8, & 12)
- Profile of Mood State(Each Visit: Week 0, 2, 4, 6, 8, & 12)
研究者
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